SchizophreniaPhase 1NCT06504290
Evaluating Safety, Tolerability and Pharmacokinetic of Multiple Ascending Doses of VV119
A Phase 1 study testing VV119 （in healthy adult subjects） and VV119(in adult patients with schizophrenia) in people with Schizophrenia, run by Vigonvita Life Sciences at 4 sites in China.
Trial summary
This study will consist of 2 parts: Part Ⅰ-in healthy adult subjects, Part Ⅱ-in adult patients with schizophrenia Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- VV119 （in healthy adult subjects） and VV119(in adult patients with schizophrenia)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 4 sitesChina
- Study dates
- 16 Jul 2024to 1 Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult subjects：
- Males: aged 18 to 45 years old, Body weight no less than 50.0kg; females: Aged 18 to 60 years old, Body weight no less than 45.0kg, Body Mass Index of 19.0 to 26.0kg/m2.
- Medically healthy, physical examination, vital signs examination, laboratory examination, electrocardiogram examination results were normal or abnormal without clinical significance.
- Males' subjects who are willing to take effective contraceptive during the study and within 6 months after the study completed; females of non-child-bearing potential.
- Subjects who are able to understand and follow study plans and instructions; Subjects who have voluntarily decided to participate in this study and signed the informed consent form.
- Adult patients with schizophrenia:
Show all 13Show fewer
- Aged 18 to 65 years old, Body Mass Index of 18.5 to 30kg/m2, males, Body weight no less than 50.0kg; females: Body weight no less than 45.0kg.
- Males' subjects who are willing to take effective contraceptive during the study and within 6 months after the study completed; females of non-child-bearing potential.
- Subject has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the DSM-5 and MINI at least 1 year.
- Subject is experiencing an acute exacerbation or relapse of psychotic symptoms.
- PANSS total score at least 70 and CGI-S score of ≥4 at screening.
- Subjects who have a history of antipsychotics.
- The subjects and their guardians fully understand the purpose and requirements of the trial, voluntarily participate in the clinical trial and sign the written informed consent form and are willing to complete the whole trial process according to the trial requirements.
Who cannot join
- Healthy adult subjects：
- With current or past medical history diseases or dysfunction that affect the clinical trial, evaluated by the investigator, including but not limited to central nervous system, cardiovascular system, respiratory system, digestive system, urinary system, endocrine system, blood system, ophthalmology and other diseases, history of malignant tumor or other diseases that are not suitable for participating in the clinical trial.
- With current or previous mental disorders and brain dysfunction, or suicide risk according to the clinical judgment of the investigator, or a history of self-mutilation.
- With any surgical condition or condition that may significantly affect the absorption, distribution, metabolism and excretion of the drug, or may pose a hazard to the subjects participating in the trial, such as history of gastrointestinal surgery (gastrectomy, gastrointestinal anastomosis, intestinal resection, etc.), urinary tract obstruction or dysuria, gastroenteritis, gastrointestinal ulcers, history of gastrointestinal bleeding, etc.
- With a known history of allergy to investigating drug ingredients or similar drugs, a history of allergic diseases or allergic constitution.
- Positive for hepatitis B virus surface antigen （HBsAg）, or syphilis antibody (Anti-TP), or hepatitis C antibody (anti-HCV), or human immunodeficiency virus antigen/antibody combined detection (HIV-Ag/Ab).
Show all 45Show fewer
- With a history of surgery within 3 months before screening, or have not recovered from surgery, or have an expected surgical plan during the trial.
- With a blood donation or blood loss ≥ 400mL within 3 months before screening, or a blood donation or blood loss ≥ 200mL within 1 month, or a history of blood product use within 3 months before screening.
- Taking any prescription drugs, over-the-counter drugs, and any functional vitamins or herbal products within 2 weeks before screening.
- Using any drugs that inhibit or induce hepatic drug metabolizing enzymes CYP3A4, CYP3A5, CYP2D6 (such as inducers - phenobarbital, rifampicin, carbamazepine, phenytoin sodium, glucocorticoids, etc.; inhibitors - ketoconazole, itraconazole, cimetidine, clarithromycin, verapamil, erythromycin, etc.) within 4 weeks (or 5 half-lives, whichever is longer) before screening.
- Participating in any clinical trial and taking clinical trial drugs within 3 months before screening, or being participating in other clinical trials.
- Smoke test positive or smoking more than 5 cigarettes per day or average intake of coffee or tea more than 5 cups per day (200 mL/cup) within 3 months before screening, or unable to stop users during the study.
- With alcohol abuse within 1 year before screening, average weekly alcohol intake more than 14 standard units [1 unit = 360 mL beer (alcohol content 5%) or 45 mL spirits (alcohol content 40%) or 150 mL wine (alcohol content 12%)] or positive for alcohol breath test.
- With a history of drug abuse within 1 year before screening, or positive for urine drug screening.
- With a family history of sudden cardiac death (sudden death age less than 40 years).
- With a resting pulse < 50 beats/min or ≥ 100 beats/min; resting systolic blood pressure < 85 mmHg or ≥ 140 mmHg; resting diastolic blood pressure < 50 mmHg or ≥ 90 mmHg; systolic blood pressure decreased by ≥ 20 mmHg and/or diastolic blood pressure decreased by ≥ 10 mmHg and/or accompanied by clinical symptoms within 3 minutes of standing.
- Abnormal in 12-lead electrocardiogram (ECG), clinically significant judged by the investigator (e.g., QTcF> 450 ms in men and > 470 ms in women).
- With the aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatinine (Cr), urea (Urea), serum prolactin levels beyond the upper limit of normal (ULN)，Neutrophil count below the lower limit of normal (LLN).
- Having special requirements for food, unable to observe a unified diet or having dysphagia.
- Rejecting abide by the following conditions during the trial: smoking, alcohol or caffeine-containing beverages are prohibited, and strenuous exercise is avoided.
- Directly related to this clinical trial.
- Other subjects that the investigator considers inappropriate for this trial.
- Adult patients with schizophrenia:
- Patients who meet the DSM-5 diagnostic criteria for other mental diseases.
- Patients with refractory schizophrenia to be defined as patients with treatment-resistant schizophrenia who have not achieved clinical improvement after a full course of treatment with at least 2 antipsychotics in the past 5 years.
- The answer to question 4 or 5 of the Columbia Suicide Scale (C-SSRS) suicide ideation in the screening period is "yes", or the person who has obvious suicide tendency at present or in the past 12 months, or the researcher believes that there is a risk of suicide and violence based on the clinical evaluation of the investigator.
- There are diseases or functional disorders that affect the clinical trial, including but not limited to neuropsychiatric, cardiovascular, urinary, digestive, respiratory, muscular, metabolic endocrine, hematology, immunology, skin and tumors, etc., clinically significant chronic diseases or poorly controlled diseases that have an impact on this trial as assessed by the investigator.
- With any surgical condition or condition that may significantly affect the absorption, distribution, metabolism and excretion of the drug, or may pose a hazard to the subjects participating in the trial, such as history of gastrointestinal surgery (gastrectomy, gastrointestinal anastomosis, intestinal resection, etc.), urinary tract obstruction or dysuria, gastroenteritis, gastrointestinal ulcers, history of gastrointestinal bleeding, etc.
- With a history of epilepsy (except for febrile convulsion).
- With a history of Malignant syndrome.
- With a history of severe allergies.
- Received electric shock treatment, and transcranial magnetic stimulation (rTMS) within 3 months before screening;
- Subjects are receiving or have recently received (within 5 half-lives, before baseline [Day -1]) oral antipsychotic medications, antidepressants or mood stabilizers.
- CYP3A4 or CYP2D6 potent inhibitors, moderate inhibitors, potent inducers and moderate inducers used within 5 half-lives before enrollment.
- Those who have physical examination abnormalities unrelated to schizophrenia at screening, which are judged by the investigator to have an impact on this trial.
- With a resting pulse < 50 beats/min or ≥ 100 beats/min; resting systolic blood pressure < 85 mmHg or ≥ 140 mmHg; resting diastolic blood pressure < 50 mmHg or ≥ 90 mmHg; systolic blood pressure decreased by ≥ 20 mmHg and/or diastolic blood pressure decreased by ≥ 10 mmHg and/or accompanied by clinical symptoms within 3 minutes of standing.
- Abnormal in 12-lead electrocardiogram （ECG）, clinically significant judged by the investigator (e.g., QTcF> 450ms in men and > 470ms in women).
- The laboratory examination during the screening period was abnormal, and the researcher determined that it was of obvious clinical significance, such as: glutamate aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 1.5 times the upper limit of the normal value;creatinine (Cr)>upper limit of normal value;serum prolactin levels ≥ 5 times the upper limit of the normal value
- With a history of drug abuse within 1 year before screening, or positive for urine drug screening.
- With alcohol abuse within 1 year before screening, average weekly alcohol intake more than 14 standard units [1 unit = 360mL beer (alcohol content 5%) or 45mL spirits （alcohol content 40%） or 150mL wine （alcohol content 12%）] or positive for alcohol breath test.
- Rejecting abides by the following conditions during the trial: smoking, alcohol or caffeine-containing beverages are prohibited, and strenuous exercise is avoided.
- Positive for hepatitis B virus surface antigen （HBsAg）, or syphilis antibody (Anti-TP), or hepatitis C antibody (anti-HCV), or human immunodeficiency virus antigen/antibody combined detection (HIV-Ag/Ab).
- With a blood donation or blood loss ≥ 400mL within 3 months before screening, or a blood donation or blood loss ≥ 200mL within 1 month.
- Participation in another clinical study within 3 months before screening in which the subject received an experimental or investigational drug agent,or are participating in clinical trials.
- Other subjects that the investigator considers inappropriate for this trial.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Beijing Anding Hospital of Capital Medical University
Beijing, Beijing Municipality
Gang Wang
- Recruiting
Beijing Anding Hospital of Capital Medical University
Beijing, Beijing Municipality
Anning Li
- Recruiting
Beijing Huilongguan Hospital
Beijing, Beijing Municipality
Fude Yang
- Recruiting
Xi'an Mental Health Center
Xi’an, Shanxi
Rong Zhuang
About this study
Official title: A Phase I Clinical Study Evaluating the Safety, Tolerability, and Pharmacokinetics of VV119 Capsules With Multiple Ascending Doses in Chinese Healthy Adult Subjects and Patients With Schizophrenia
This study will consist of 2 parts: Part Ⅰ-in healthy adult subjects, Part Ⅱ-in adult patients with schizophrenia
Read the detailed description
Part Ⅰ was designed as single-center, randomized, double-blind, placebo-controlled, dose-escalation trial to assess the safety, tolerability, pharmacokinetics （PK） of multiple doses of VV119 in Chinese healthy adult subjects.
Part Ⅱ was designed as multicenter, randomized, double-blind, placebo-controlled, dose-escalation trial to assess the safety, tolerability, pharmacokinetics （PK） and efficacy of multiple doses of VV119 in adult patients with schizophrenia.
- Conditions
- Schizophrenia
- Being tested
- VV119 Placebo （in healthy adult subjects）, VV119 （in healthy adult subjects）, VV119(in adult patients with schizophrenia), VV119 Placebo （in adult patients with schizophrenia）
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VV119 Placebo （in healthy adult subjects）Drug
VV119 0.5 mg Group:2 subjects will receive VV119 Placebo 0.5 mg, orally once daily for 14 days.
VV119 1 mg Group:2 subjects will receive VV119 Placebo 1 mg, orally once daily for 14 days.
VV119 （in healthy adult subjects）Drug
VV119 0.5 mg Group:6 subjects will receive VV119 0.5 mg, orally once daily for 14 days.
VV119 1 mg Group:6 subjects will receive VV119 1 mg, orally once daily for 14 days.
VV119(in adult patients with schizophrenia)Drug
VV119 2 mg Group:6 subjects will receive 2 0.5mgVV119 capsules on the first four days, then take 1 2mgVV119 capsules and 1 0.5mg VV119 Placebo from the fifth day to the 28th day， orally once daily, VV119 4 mg Group:6 subjects will receive 2 0.5mgVV119 capsules on the first four days, take 1 2mgVV119 capsules and 1 0.5mg VV119 Placebo from the fifth day to the seventh day , then 2 2mgVV119 capsules and 1 0.5mg VV119 Placebo from the eighth day to the 28th day ,orally once daily, VV119 6 mg Group:6 subjects will receive 2 0.5mgVV119 capsules on the first three days,take 1 2mgVV119 capsules and 1 0.5mg VV119 Placebo from the forth day to the fifth day , take 2 2mgVV119 capsules and 1 0.5mg VV119 Placebo from the sixth day to the seventh day , then 3 2mgVV119 capsules and 1 0.5mg VV119 Placebo from the eighth day to the 28th day ,orally once daily.
VV119 Placebo （in adult patients with schizophrenia）Drug
VV119 2 mg Group:2 subjects will receive 1 0.5mgVV119 capsules and 1 0.5mg VV119 Placebo on the first four days, then take 1 2mgVV119 Placebo and 1 0.5mg VV119 capsules from the fifth day to the 28th day， orally once daily, VV119 4 mg Group:2 subjects will receive 1 0.5mgVV119 capsules and 1 0.5mg VV119 Placebo on the first four days, take 1 2mgVV119 Placebo and 1 0.5mg VV119 capsules from the fifth day to the seventh day , then 2 2mgVV119 Placebo and 1 0.5mg VV119 capsules from the eighth day to the 28th day ,orally once daily, VV119 6 mg Group:2 subjects will receive 1 0.5mgVV119 capsules and 1 0.5mg VV119 Placebo on the first three days, take 1 2mgVV119 Placebo and 1 0.5mg VV119 capsules from the forth day to the fifth day ,take 2 2mgVV119 capsules and 1 0.5mg VV119 Placebo from the sixth day to the seventh day, then 3 2mgVV119 Placebo and 1 0.5mg VV119 capsules from the eighth day to the 28th day ,orally once daily.
| Study group | Role | What they receive |
|---|---|---|
| Part Ⅰ- in healthy adult subjects | Experimental | Not described Receives: Drug: VV119 Placebo （in healthy adult subjects）; Drug: VV119 （in healthy adult subjects） |
| Part Ⅱ-in adult patients with schizophrenia | Experimental | Not described Receives: Drug: VV119(in adult patients with schizophrenia); Drug: VV119 Placebo （in adult patients with schizophrenia） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events
Measured: Baseline to 15 days after the last administration
Secondary outcomes (16)
Cmax
maximum observed plasma concentration of VV119 and the main metabolites
Measured: Baseline to 360 hours after the last administration
area under the plasma concentration time curve from time zero to the last (AUC0-t)
area under the plasma concentration time curve from time zero to the last of VV119 and the main metabolites
Measured: Baseline to 360 hours after the last administration
AUC0-∞
area under the plasma concentration time curve from time zero to infinity of VV119 and the main metabolites
Measured: Baseline to 360 hours after the last administration
Tmax
time at which Cmax occurs of VV119 and the main metabolites of VV119 and the main metabolites
Measured: Baseline to 360 hours after the last administration
t1/2
half-life of elimination of VV119 and the main metabolites
Measured: Baseline to 360 hours after the last administration
Apparent Clearance Rate（CL/F）
apparent clearance of VV119 and the main metabolites
Measured: Baseline to 360 hours after the last administration
Vd/F
apparent volume of distribution during the terminal phase of VV119 and the main metabolites
Measured: Baseline to 360 hours after the last administration
Ke
elimination rate constant of VV119 and the main metabolites
Measured: Baseline to 360 hours after the last administration
AUC0-24h
area under the plasma concentration time curve from time zero to 24h of VV119 and the main metabolites
Measured: Baseline to 360 hours after the last administration
mean Resident Time
mean Resident Time from time zero to infinity/the last of VV119 and the main metabolites
Measured: Baseline to 360 hours after the last administration
Positive and Negative Syndrome Scale （PANSS）
Change from Baseline in Positive and Negative Syndrome Scale in part Ⅱ。 The PANSS measures symptom severity of participants with schizophrenia and contains 7 positive symptom scales,7negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale with a total minimum score of 30 and a maximum score of 210. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.
Measured: Day-1,Day14,Day28 and Day42
PANSS Positive subscale score
Change from Baseline in PANSS Positive subscale score in part Ⅱ PANSS-Positive: Assessment of positive symptoms. Minimum value:7, maximum value:49, the higher scores mean a worse outcome.
Measured: Day-1, Day14, Day28 and Day42
PANSS Negative subscale score
Change from Baseline in PANSS Negative subscale score in part Ⅱ。 PANSS-negative: Assessment of negative symptoms. Minimum value:7, maximum value:49, the higher scores mean a worse outcome.
Measured: Day-1, Day14, Day28 and Day42
Treatment response rate
Positive and Negative Syndrome Scale （PANSS） Response rate, Defined as a 50% or Greater Improvement from Baseline in PANSS Total Score in part Ⅱ
Measured: Day-1,Day14, Day28 and Day42
Clinical Global Impression-Severity (CGI-S)
Change from Baseline in Clinical Global Impression-Severity in part Ⅱ。 The CGI-S rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Negative change from baseline scores indicate improvement in the severity of illness.
Measured: Day-14, Day28 and Day42
Rac
Accumulation Ratio of VV119
Measured: Baseline to 360 hours after the last administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start16 Jul 2024
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Vigonvita Life SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vigonvita Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gang Wang, Principal investigator, Beijing Anding Hospital of Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06504290
- Sponsor's protocol ID
- VV119-02
- Status last verified
- Apr 2026
- First submitted
- 2 Jul 2024
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study Evaluating the Safety, Tolerability, and Pharmacokinetics of VV119 Capsules With Multiple Ascending Doses in Chinese Healthy Adult Subjects and Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT06504290
- Acronym / sponsor ID
- VV119-02
- Conditions
- Schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Vigonvita Life SciencesIndustry (pharma, biotech, devices)
- Study start
- 16 Jul 2024 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 16 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will consist of 2 parts: Part Ⅰ-in healthy adult subjects, Part Ⅱ-in adult patients with schizophrenia
Detailed description
Part Ⅰ was designed as single-center, randomized, double-blind, placebo-controlled, dose-escalation trial to assess the safety, tolerability, pharmacokinetics （PK） of multiple doses of VV119 in Chinese healthy adult subjects.
Part Ⅱ was designed as multicenter, randomized, double-blind, placebo-controlled, dose-escalation trial to assess the safety, tolerability, pharmacokinetics （PK） and efficacy of multiple doses of VV119 in adult patients with schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part Ⅰ- in healthy adult subjects | Experimental | Drug: VV119 Placebo （in healthy adult subjects）, Drug: VV119 （in healthy adult subjects） |
| Part Ⅱ-in adult patients with schizophrenia | Experimental | Drug: VV119(in adult patients with schizophrenia), Drug: VV119 Placebo （in adult patients with schizophrenia） |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Healthy adult subjects：
- Males: aged 18 to 45 years old, Body weight no less than 50.0kg; females: Aged 18 to 60 years old, Body weight no less than 45.0kg, Body Mass Index of 19.0 to 26.0kg/m2.
- Medically healthy, physical examination, vital signs examination, laboratory examination, electrocardiogram examination results were normal or abnormal without clinical significance.
- Males' subjects who are willing to take effective contraceptive during the study and within 6 months after the study completed; females of non-child-bearing potential.
- Subjects who are able to understand and follow study plans and instructions; Subjects who have voluntarily decided to participate in this study and signed the informed consent form.
Key exclusion criteria (45 listed)
- Healthy adult subjects：
- With current or past medical history diseases or dysfunction that affect the clinical trial, evaluated by the investigator, including but not limited to central nervous system, cardiovascular system, respiratory system, digestive system, urinary system, endocrine system, blood system, ophthalmology and other diseases, history of malignant tumor or other diseases that are not suitable for participating in the clinical trial.
- With current or previous mental disorders and brain dysfunction, or suicide risk according to the clinical judgment of the investigator, or a history of self-mutilation.
- With any surgical condition or condition that may significantly affect the absorption, distribution, metabolism and excretion of the drug, or may pose a hazard to the subjects participating in the trial, such as history of gastrointestinal surgery (gastrectomy, gastrointestinal anastomosis, intestinal resection, etc.), urinary tract obstruction or dysuria, gastroenteritis, gastrointestinal ulcers, history of gastrointestinal bleeding, etc.
- With a known history of allergy to investigating drug ingredients or similar drugs, a history of allergic diseases or allergic constitution.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VV119 Placebo （in healthy adult subjects）VV119 0.5 mg Group:2 subjects will receive VV119 Placebo 0.5 mg, orally once daily for 14 days. VV119 1 mg Group:2 subjects will receive VV119 Placebo 1 mg, orally once daily for 14 days. | Drug | Part Ⅰ- in healthy adult subjects |
| VV119 （in healthy adult subjects）VV119 0.5 mg Group:6 subjects will receive VV119 0.5 mg, orally once daily for 14 days. VV119 1 mg Group:6 subjects will receive VV119 1 mg, orally once daily for 14 days. | Drug | Part Ⅰ- in healthy adult subjects |
| VV119(in adult patients with schizophrenia)VV119 2 mg Group:6 subjects will receive 2 0.5mgVV119 capsules on the first four days, then take 1 2mgVV119 capsules and 1 0.5mg VV119 Placebo from the fifth day to the 28th day， orally once daily, VV119 4 mg Group:6 subjects will receive 2 0.5mgVV119 capsules on the first four days, take 1 2mgVV119 capsules and 1 0.5mg VV119 Placebo from the fifth day to the seventh day , then 2 2mgVV119 capsules and 1 0.5mg VV119 Placebo from the eighth day to the 28th day ,orally once daily, VV119 6 mg Group:6 subjects will receive 2 0.5mgVV119 capsules on the first three days,take 1 2mgVV119 capsules and 1 0.5mg VV119 Placebo from the forth day to the fifth day , take 2 2mgVV119 capsules and 1 0.5mg VV119 Placebo from the sixth day to the seventh day , then 3 2mgVV119 capsules and 1 0.5mg VV119 Placebo from the eighth day to the 28th day ,orally once daily. | Drug | Part Ⅱ-in adult patients with schizophrenia |
| VV119 Placebo （in adult patients with schizophrenia）VV119 2 mg Group:2 subjects will receive 1 0.5mgVV119 capsules and 1 0.5mg VV119 Placebo on the first four days, then take 1 2mgVV119 Placebo and 1 0.5mg VV119 capsules from the fifth day to the 28th day， orally once daily, VV119 4 mg Group:2 subjects will receive 1 0.5mgVV119 capsules and 1 0.5mg VV119 Placebo on the first four days, take 1 2mgVV119 Placebo and 1 0.5mg VV119 capsules from the fifth day to the seventh day , then 2 2mgVV119 Placebo and 1 0.5mg VV119 capsules from the eighth day to the 28th day ,orally once daily, VV119 6 mg Group:2 subjects will receive 1 0.5mgVV119 capsules and 1 0.5mg VV119 Placebo on the first three days, take 1 2mgVV119 Placebo and 1 0.5mg VV119 capsules from the forth day to the fifth day ,take 2 2mgVV119 capsules and 1 0.5mg VV119 Placebo from the sixth day to the seventh day, then 3 2mgVV119 Placebo and 1 0.5mg VV119 capsules from the eighth day to the 28th day ,orally once daily. | Drug | Part Ⅱ-in adult patients with schizophrenia |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: Baseline to 15 days after the last administration
Incidence of Treatment-Emergent Adverse Events
16 secondary outcomes
Cmax
Time frame: Baseline to 360 hours after the last administration
area under the plasma concentration time curve from time zero to the last (AUC0-t)
Time frame: Baseline to 360 hours after the last administration
AUC0-∞
Time frame: Baseline to 360 hours after the last administration
Tmax
Time frame: Baseline to 360 hours after the last administration
t1/2
Time frame: Baseline to 360 hours after the last administration
Apparent Clearance Rate（CL/F）
Time frame: Baseline to 360 hours after the last administration
Vd/F
Time frame: Baseline to 360 hours after the last administration
Ke
Time frame: Baseline to 360 hours after the last administration
AUC0-24h
Time frame: Baseline to 360 hours after the last administration
mean Resident Time
Time frame: Baseline to 360 hours after the last administration
Positive and Negative Syndrome Scale （PANSS）
Time frame: Day-1,Day14,Day28 and Day42
PANSS Positive subscale score
Time frame: Day-1, Day14, Day28 and Day42
PANSS Negative subscale score
Time frame: Day-1, Day14, Day28 and Day42
Treatment response rate
Time frame: Day-1,Day14, Day28 and Day42
Clinical Global Impression-Severity (CGI-S)
Time frame: Day-14, Day28 and Day42
Rac
Time frame: Baseline to 360 hours after the last administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Recruiting
MI-CBTech: A Mobile Intervention for Community Integration in Homeless-Experienced Veterans With SMI
Schizophrenia Spectrum Disorders, Psychotic Affective Disorders
RecruitingObservational study
Tau Biomarkers in Late-onset Psychosis (LOP)
Late Onset Schizophrenia, Delusional Disorder (Late Onset)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gang Wang principal investigator
Beijing Anding Hospital of Capital Medical University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VV119 （in healthy adult subjects） and VV119(in adult patients with schizophrenia) in people with Schizophrenia, run by Vigonvita Life Sciences at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 45 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huaqing Duan (+8618061926005, huaqing.duan@vigonvita.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: Baseline to 15 days after the last administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.